SAO PAULO (Reuters) - Brazil’s Parana state is in talks to produce a COVID-19 vaccine approved by Russia despite not having completed mass clinical trials, but it was unclear if the state’s research institute would get regulatory approval in Brazil.
Tuesday’s announcement by the Parana Technology Institute (Tecpar) took Brazil’s regulators and health experts by surprise, with some raising doubts about the institute’s capacity to produce large volumes of a new vaccine from scratch.
The Parana government said in a statement that Governor Ratinho Júnior was set to meet the Russian ambassador to Brazil on Wednesday to discuss the terms of an agreement.
With the world’s biggest coronavirus outbreak outside the United States, Brazil has become a hub for mass clinical trials of potential vaccines. Brazilian officials have vowed to start producing British and Chinese vaccines within a year, but experts warn it may take at least twice as long.
Moscow’s decision to grant approval for its vaccine before completing clinical trials has raised concerns among some experts. About 10% of clinical trials are successful.
Moscow on Tuesday hailed its breakthrough, after less than two months of human testing, as evidence of Russia’s scientific prowess.
Russian business conglomerate Sistema has said it expects mass production by the end of the year.
Any production arrangement in Brazil would require approval by health regulator Anvisa. The agency said it had not yet received a request to authorize the Russian vaccine and that it could not comment on its safety or effectiveness before receiving data from the laboratory responsible for development.
Ivo Bucaresky, a former Anvisa director, urged caution, given the speed of the Russian vaccine’s development and incomplete testing.
“I would be afraid of Russia’s vaccine,” Bucaresky said in a telephone interview. “The Russian government was very bold, if not to say irresponsible, to put out a vaccine that had hardly been tested to vaccinate its population,” he added.
Two other former senior Anvisa officials told Reuters they did not believe Tecpar had the capability to mass produce the vaccine. One of them, a former head of the agency, said Tecpar now produces only one vaccine - to protect animals against rabies. Both sources requested anonymity to speak frankly.
The Parana government dismissed the concerns, stressing in its statement that Tecpar has the “technical capacity to participate in the process.”
Former Brazilian Health Minister Luiz Henrique Mandetta said political pressure to be the first with a vaccine was prevailing over scientific caution. But he said Parana had the technical ability to produce a vaccine and Brazil had clear requirements for testing before approval.
Besides, he told Reuters, “if Russia vaccinates 150 million of its citizens, that should be a good thermometer.”
Brazil has reported more than 3 million cases of the novel coronavirus as President Jair Bolsonaro urges a reopening of the economy. The death toll passed 100,000 this weekend.
Reporting by Eduardo Simoes, Pedro Fonseca, Anthony Boadle and Gabriel Stargardter; Writing by Stephen Eisenhammer; Editing by Brad Haynes and Sonya Hepinstall
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